Post-Market Quality Engineer: Lead Investigations & Compliance

VB Spine, LLC; Leesburg (VA); On-site; USD 80,000 - 88,000; Full time

Benefits offered by this job

Health insurance

Dental insurance

Vision insurance

401(k) with company match

PTO

Job summary

VB Spine, LLC is seeking a Quality Engineer to support complaint intake, triage, and investigations for medical devices. You will engage with surgeons, sales teams, and field partners to clarify product performance and ensure timely root cause determination.

The role emphasizes adverse event reporting, PSUR preparation, and data-driven improvements across post-market surveillance. A Bachelor's degree in a technical field is required, with 0–1 year of related experience preferred.

Qualifications

• Bachelor’s degree in science, engineering, or related technical field required.
• 0–1 years of quality experience in medical devices preferred.
• Knowledge of risk management, CAPA, audits, statistics suggested.

Responsibilities

• Assist with complaint intake, triage, and classification per SOPs and regulations.
• Lead root cause investigations and document methodologies.
• Gather clinical context from surgeons, sales, and field partners to support root cause decisions.
• Determine reportability and prepare adverse event submissions to authorities.
• Contribute to PSURs, Canadian summaries, and other regional reports.
• Perform trending analysis to identify product safety signals.

Skills

Quality concepts

Root-cause investigations

Cross-functional teamwork

Power BI

Automation/Coding basics

Education

Bachelor’s degree in science/engineering

Tools

Power BI

Coding

Automation

Job description

VB Spine, LLC is seeking a Quality Engineer to support complaint intake, triage, and investigations for medical devices. You will engage with surgeons, sales teams, and field partners to clarify product performance and ensure timely root cause determination.

The role emphasizes adverse event reporting, PSUR preparation, and data-driven improvements across post-market surveillance. A Bachelor's degree in a technical field is required, with 0–1 year of related experience preferred.